The Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level

Yonsei University

Status: Completed

Conditions: LDL-cholesterol Level 130-159mg/dL

Treatments: Other: Yoghurt drink without plant stanol as esters; Other: Yoghurt drink containing plant stanol as esters

Study type: Interventional

Funder types: Other

Identifiers

NCT02779673

LF_cholesterol

Details and patient eligibility

About

The purpose of randomized, double-blind, placebo-controlled study was to determine whether yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.

Full description

The objective of clinical trial was to evaluate the effect of yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) on blood cholesterol level. A randomized, double-blinded, placebo-controlled study was conducted on subjects with LDL-cholesterol level 130-159mg/dL. The subjects were randomly assigned to either a group ingesting yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) or a placebo group (yoghurt drink without plant stanols) for 4-week. The investigators assessed blood cholesterol level.

Enrollment: 69 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• LDL-cholesterol level 130-159mg/dL (not taking cholesterol-lowering medications)

Exclusion criteria

• taking any medications (including anti-hypertensive, lipid lowering, anti-platelets, and anti-diabetic drugs)
• history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
• history or presence of cancer
• history of a psychiatric disorder and/or drug or alcohol abuse or dependency;
• having a known intolerance to gluten or lactose
• having a known allergy to any ingredient in the investigational product
• women who are pregnant or desire to become pregnant during the study period or within 3 months of giving birth or breast feeding or within 3 months of cessation of breast feeding
• having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 2 patient groups, including a placebo group

Test group

Experimental group

Description:

Subjects randomized to the test group consumed yoghurt drink containing 3.4g plant stanol as ester for 1 per day for a period of 4 weeks.

Treatment:

Other: Yoghurt drink containing plant stanol as esters

Placebo group

Placebo Comparator group

Description:

Subjects randomized to the placebo group consumed yoghurt drink without plant stanol as ester for 1 per day for a period of 4 weeks.

Treatment:

Other: Yoghurt drink without plant stanol as esters